It is widely known that high levels of cholesterol can create various health complications. For example, high levels of cholesterol have been directly linked with blockages in arteries which restrict and impede blood flow to vital organs in the body. Additionally, cholesterol is known to be present in gallstones, in various cysts and in carcinomatous tissue. For these and other reasons, the reduction of unnecessarily high cholesterol levels is desirable.
Without question, in the vast majority of cases the most effective way to reduce cholesterol levels is with a proper diet. Unfortunately, not everyone is able or willing to discipline themselves to maintain such a diet. Further, it may be that diet alone is ineffective for reducing cholesterol in the system to a desired level. Thus, where high cholesterol levels have been identified as a potential health problem, and dieting is either undesirable or ineffective, various alternatives to the strict diet approach for confronting the problem have been suggested. For example, dietary fibers, such as chitin and chitosan, have been successful in lowering blood cholesterol levels in laboratory animals. These drugs have also had some success in human experiments. Another dietary fiber, cholestyramine an edible anion exchange resin, has been found to be particularly effective for lowering cholesterol levels in humans when ingested in accordance with a prescribed regimen.
Edible anion exchange resins such as cholestyramine, colestipol and the like are chemicals that combine with bile acids and cholesterol in the stomach and intestines. Then, rather than being absorbed into the body's blood system, the bound cholesterol and bound bile acids are excreted and eliminated from the body without effect. Such resins, however, have a very unpleasant taste when ingested alone. Further, ingestible resins have a sand-like constituency which can be difficult to prepare for consumption. Throughout the following discussion, colestipol may be used interchangeably with or instead of cholestyramine.
Presently, in order to make cholestyramine palatable, it is necessary to mix cholestyramine granules With a carrier such as orange juice. This delivery system, however, requires preparation and planning in that the cholestyramine must be stirred up in the juice and ingested before it can settle out. This may require repetitive efforts and can be quite bothersome.
Delivery systems different from orange juice can obviously be proposed. Cholestyramine, however, because of its sand-like constituency, it not an easy material to work with. Indeed, the sand-like characteristic of cholestyramine causes its mixture with certain matrix elements to behave as a Bingham plastic. The result is a composition which is very resistive to mixing or agitation. Nevertheless, the present invention recognizes that cholestyramine can be mixed with a gelatin frappe, in accordance with selected procedures, to produce an acceptable delivery system in spite of any material processing difficulties. In the contemplation of the present invention, this delivery system will resemble the well known and familiar candy bar.
The present invention provides a method for preparing an edible anion exchange resin delivery system which is acceptable for ingestion by a human. In addition, the present invention sets forth a method which makes a cholestyramine delivery system that tastes good and is easy to ingest and which allows edible anion exchange resins to be easily and efficaciously ingested with little, if any, pre-ingestion preparation. A simple cost effective procedure for preparing an edible anion exchange resin delivery system which can be efficaciously followed in spite of the delivery system's tendency to exhibit the characteristics of a Bingham plastic is also described.
Cholestyramine as used herein is representative of the class of compounds known as edible anion exchange resins. This class of compounds is useful in the present invention. Anion exchange resins useful in the present invention include those anion exchange resins having anticholesteremic properties which promote a reduction of cholesterol levels in the blood. Preferred anion exchange resins include cholestyramine, colestipol and anion exchange resins having the imidazolium group as the functional group. Preferred resins of the imidazolium type are described in U.S. Pat. No. 4,557,930 the entire contents of which are hereby incorporated by reference.